Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03280108
Collaborator
(none)
250
Enrollment
12
Locations
2
Arms
10.8
Actual Duration (Months)
20.8
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: AcrySof IQ PanOptix Multifocal IOL
  • Device: AcrySof Monofocal IOL
N/A

Detailed Description

Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 10 study visits over a 7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.

Study Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Sep 27, 2018
Actual Study Completion Date :
Sep 27, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: Multifocal IOL

AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).

Device: AcrySof IQ PanOptix Multifocal IOL
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision
Other Names:
  • Model TFNT00
  • AcrySof® IQ PanOptix®
  • Active Comparator: Monofocal IOL

    AcrySof Monofocal IOL Model SN60AT implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).

    Device: AcrySof Monofocal IOL
    AcrySof Monofocal IOL Model SN60AT for single vision
    Other Names:
  • Model SN60AT
  • AcrySof®
  • Outcome Measures

    Primary Outcome Measures

    1. Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m) [Month 6 (Day 120-180), post second eye implantation]

      Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

    2. Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm) [Month 6 (Day 120-180), post second eye implantation]

      VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

    3. Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye [Up to Month 6 (Day 120-180), post second eye implantation]

      The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.

    4. Mean Photopic Without Glare Binocular Distance Contrast Sensitivity [Month 6 (Day 120-180), post second eye implantation]

      Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

    5. Mean Photopic With Glare Binocular Distance Contrast Sensitivity [Month 6 (Day 120-180), post second eye implantation]

      Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

    6. Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity [Month 6 (Day 120-180), post second eye implantation]

      Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

    7. Mean Mesopic With Glare Binocular Distance Contrast Sensitivity [Month 6 (Day 120-180), post second eye implantation]

      Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

    Secondary Outcome Measures

    1. Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm) [Month 6 (Day 120-180), post second eye implantation]

      VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

    2. Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire [Month 6 (Day 120-180), post second eye implantation]

      The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" is reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.

    3. Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) [Month 6 (Day 120-180), post second eye implantation]

      QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding "Severe" was calculated as (# of subjects responding "Severe") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.

    4. Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID [Month 6 (Day 120-180), post second eye implantation]

      Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding "Bothered very much") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision

    • Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures

    • Clear intraocular media other than cataract in both eyes.

    • Preoperative keratometric astigmatism of less than 1.0 diopter (D) in both operative eyes.

    Exclusion Criteria:
    • Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema

    • Previous refractive surgery or refractive surgery procedures (including, but not limited to LASIK, astigmatic keratotomy, and limbal relaxing incisions)

    • Glaucoma (uncontrolled or controlled with medication)

    • Degenerative eye disorders (e.g. macular degeneration or other retinal disorders)

    • Pregnant or lactating

    • Expected to require a second surgical intervention or retinal laser treatment.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Alcon Investigative SiteFresnoCaliforniaUnited States93720
    2Alcon Investigative SiteMount DoraFloridaUnited States32757
    3Alcon Investigative SitePanama CityFloridaUnited States32405
    4Alcon Investigative SitePoughkeepsieNew YorkUnited States12603
    5Alcon Investigative SiteMount PleasantSouth CarolinaUnited States29464
    6Alcon Investigative SiteSioux FallsSouth DakotaUnited States57108
    7Alcon Investigative SiteNashvilleTennesseeUnited States37205
    8Alcon Investigative SiteHoustonTexasUnited States77027
    9Alcon Investigative SiteHurstTexasUnited States76054
    10Alcon Investigative SiteNacogdochesTexasUnited States75965
    11Alcon Investigative SiteSalt Lake CityUtahUnited States84107
    12Alcon Investigative SiteNorfolkVirginiaUnited States23502

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Alcon Research, Alcon Research

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03280108
    Other Study ID Numbers:
    • ILH297-C001
    First Posted:
    Sep 12, 2017
    Last Update Posted:
    Oct 10, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Alcon Research
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsSubjects were recruited from 12 investigative sites located in the United States.
    Pre-assignment DetailOf the 250 enrolled, 7 subjects were exited as screen failures prior to attempted implantation. This reporting group includes all subjects with at least one eye implanted (243).
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Period Title: Overall Study
    STARTED129114
    COMPLETED127114
    NOT COMPLETED20

    Baseline Characteristics

    Arm/Group TitleTFNT00SN60ATTotal
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.Total of all reporting groups
    Overall Participants129114243
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65.8
    (7.31)
    69.0
    (6.46)
    67.3
    (7.09)
    Sex: Female, Male (Count of Participants)
    Female
    85
    65.9%
    79
    69.3%
    164
    67.5%
    Male
    44
    34.1%
    35
    30.7%
    79
    32.5%
    Race/Ethnicity, Customized (Count of Participants)
    White
    113
    87.6%
    96
    84.2%
    209
    86%
    Black or African American
    8
    6.2%
    11
    9.6%
    19
    7.8%
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    7
    5.4%
    1
    0.9%
    8
    3.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    2
    1.8%
    2
    0.8%
    Other
    1
    0.8%
    4
    3.5%
    5
    2.1%

    Outcome Measures

    1. Primary Outcome
    TitleMean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)
    DescriptionVisual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
    Time FrameMonth 6 (Day 120-180), post second eye implantation

    Outcome Measure Data

    Analysis Population Description
    All-Implanted Analysis Set with data available at the visit
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Measure Participants127113
    Least Squares Mean (Standard Error) [logMAR]
    -0.014
    (0.0083)
    -0.039
    (0.0087)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection TFNT00, SN60AT
    Comments
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in Least Squares Means (LSM) between the 2 groups (TFNT00 - SN60AT). Non-inferiority margin = 0.10 logMAR.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterLeast Squares Mean Difference
    Estimated Value0.024
    Confidence Interval (1-Sided) 95%
    to 0.041
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.0103
    Estimation Comments
    2. Primary Outcome
    TitleMean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)
    DescriptionVA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
    Time FrameMonth 6 (Day 120-180), post second eye implantation

    Outcome Measure Data

    Analysis Population Description
    All-Implanted Analysis Set with data at visit
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Measure Participants127113
    Measure Eyes127113
    Least Squares Mean (Standard Error) [logMAR]
    0.105
    (0.0119)
    0.529
    (0.0127)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection TFNT00, SN60AT
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.001
    Comments
    MethodMixed Models Analysis
    Comments
    3. Primary Outcome
    TitleCumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye
    DescriptionThe number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.
    Time FrameUp to Month 6 (Day 120-180), post second eye implantation

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set).
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Measure Participants129114
    Measure Eyes129114
    Count of Units [Eyes]
    1
    0
    4. Primary Outcome
    TitleMean Photopic Without Glare Binocular Distance Contrast Sensitivity
    DescriptionContrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
    Time FrameMonth 6 (Day 120-180), post second eye implantation

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set with contrast sensitivity test
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Measure Participants127111
    3 cpd
    1.752
    (0.2080)
    1.733
    (0.1989)
    6 cpd
    1.923
    (0.2349)
    1.940
    (0.2328)
    12 cpd
    1.527
    (0.2793)
    1.558
    (0.2566)
    18 cpd
    0.993
    (0.2874)
    1.090
    (0.2661)
    5. Primary Outcome
    TitleMean Photopic With Glare Binocular Distance Contrast Sensitivity
    DescriptionContrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
    Time FrameMonth 6 (Day 120-180), post second eye implantation

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set with contrast sensitivity test
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Measure Participants127111
    3 cpd
    1.759
    (0.1890)
    1.753
    (0.1928)
    6 cpd
    1.897
    (0.2322)
    1.971
    (0.1952)
    12 cpd
    1.566
    (0.2728)
    1.593
    (0.2659)
    18 cpd
    1.037
    (0.2762)
    1.121
    (0.2537)
    6. Primary Outcome
    TitleMean Mesopic Without Glare Binocular Distance Contrast Sensitivity
    DescriptionContrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
    Time FrameMonth 6 (Day 120-180), post second eye implantation

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set with contrast sensitivity test
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Measure Participants127111
    1.5 cpd
    1.673
    (0.2601)
    1.679
    (0.2190)
    3 cpd
    1.717
    (0.2397)
    1.689
    (0.2177)
    6 cpd
    1.715
    (0.2875)
    1.777
    (0.2871)
    12 cpd
    1.211
    (0.4047)
    1.290
    (0.4384)
    7. Primary Outcome
    TitleMean Mesopic With Glare Binocular Distance Contrast Sensitivity
    DescriptionContrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
    Time FrameMonth 6 (Day 120-180), post second eye implantation

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set with contrast sensitivity test
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Measure Participants127111
    1.5 cpd
    1.658
    (0.2296)
    1.678
    (0.2091)
    3 cpd
    1.709
    (0.2307)
    1.692
    (0.2089)
    6 cpd
    1.691
    (0.3238)
    1.786
    (0.2775)
    12 cpd
    1.129
    (0.4146)
    1.233
    (0.4599)
    8. Secondary Outcome
    TitleMean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)
    DescriptionVA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
    Time FrameMonth 6 (Day 120-180), post second eye implantation

    Outcome Measure Data

    Analysis Population Description
    All-Implanted Analysis Set with data at visit
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Measure Participants127113
    Measure Eyes127113
    Least Squares Mean (Standard Error) [logMAR]
    0.070
    (0.0108)
    0.327
    (0.0114)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection TFNT00, SN60AT
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.001
    Comments
    MethodMixed Models Analysis
    Comments
    Method of EstimationEstimation ParameterLeast Squares Mean Difference
    Estimated Value-0.257
    Confidence Interval (2-Sided) 95%
    -0.287 to -0.227
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.0153
    Estimation Comments
    9. Secondary Outcome
    TitleProportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire
    DescriptionThe IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" is reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.
    Time FrameMonth 6 (Day 120-180), post second eye implantation

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects with bilateral implantation and concordant, non-missing data.
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Measure Participants123110
    Number [percentage of subjects]
    80.5
    8.2
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection TFNT00, SN60AT
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterMantel-Haenszel common difference
    Estimated Value71.2
    Confidence Interval (2-Sided) 95%
    61.87 to 80.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    TitleRate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)
    DescriptionQUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding "Severe" was calculated as (# of subjects responding "Severe") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
    Time FrameMonth 6 (Day 120-180), post second eye implantation

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects with bilateral implantation and non-missing data.
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Measure Participants127111
    Starbursts
    20
    15.5%
    2
    1.8%
    Halos
    16
    12.4%
    1
    0.9%
    Glare
    4
    3.1%
    2
    1.8%
    Hazy vision
    0
    0%
    0
    0%
    Blurred vision
    0
    0%
    0
    0%
    Double vision
    0
    0%
    0
    0%
    Dark area
    0
    0%
    0
    0%
    11. Secondary Outcome
    TitleRate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID
    DescriptionSubjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding "Bothered very much") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
    Time FrameMonth 6 (Day 120-180), post second eye implantation

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects with bilateral implantation and non-missing data.
    Arm/Group TitleTFNT00SN60AT
    Arm/Group DescriptionAcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
    Measure Participants127111
    Starbursts
    6
    4.7%
    1
    0.9%
    Halos
    3
    2.3%
    1
    0.9%
    Glare
    2
    1.6%
    1
    0.9%
    Hazy vision
    0
    0%
    1
    0.9%
    Blurred vision
    0
    0%
    2
    1.8%
    Double vision
    0
    0%
    0
    0%
    Dark area
    0
    0%
    0
    0%

    Adverse Events

    Time FrameImplantation through study completion, an average of 7 months
    Adverse Event Reporting Description Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
    Arm/Group TitlePreoperativeTFNT00 - 1st EyeTFNT00 - 2nd EyeTFNT00 - SystemicSN60AT - 1st EyeSN60AT - 2nd EyeSN60AT - Systemic
    Arm/Group DescriptionAll subjects in the safety analysis set prior to initiation of treatment.All first study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.All second study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.All subjects implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.All first study eyes implanted with AcrySof Monofocal IOL Model SN60AT.All second study eyes implanted with AcrySof Monofocal IOL Model SN60AT.All subjects implanted with AcrySof Monofocal IOL Model SN60AT.
    All Cause Mortality
    PreoperativeTFNT00 - 1st EyeTFNT00 - 2nd EyeTFNT00 - SystemicSN60AT - 1st EyeSN60AT - 2nd EyeSN60AT - Systemic
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/243 (0%) 0/129 (0%) 0/127 (0%) 0/129 (0%) 0/114 (0%) 0/111 (0%) 0/114 (0%)
    Serious Adverse Events
    PreoperativeTFNT00 - 1st EyeTFNT00 - 2nd EyeTFNT00 - SystemicSN60AT - 1st EyeSN60AT - 2nd EyeSN60AT - Systemic
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/243 (0%) 2/129 (1.6%) 2/127 (1.6%) 4/129 (3.1%) 2/114 (1.8%) 1/111 (0.9%) 3/114 (2.6%)
    Cardiac disorders
    Acute myocardial infarction0/243 (0%) 0/129 (0%) 0/127 (0%) 1/129 (0.8%) 0/114 (0%) 0/111 (0%) 0/114 (0%)
    Eye disorders
    Age-related macular degeneration0/243 (0%) 0/129 (0%) 0/127 (0%) 0/129 (0%) 1/114 (0.9%) 1/111 (0.9%) 0/114 (0%)
    Cystoid macular oedema0/243 (0%) 0/129 (0%) 1/127 (0.8%) 0/129 (0%) 0/114 (0%) 0/111 (0%) 0/114 (0%)
    Posterior capsule rupture0/243 (0%) 0/129 (0%) 0/127 (0%) 0/129 (0%) 1/114 (0.9%) 0/111 (0%) 0/114 (0%)
    Vitreous prolapse0/243 (0%) 0/129 (0%) 1/127 (0.8%) 0/129 (0%) 0/114 (0%) 0/111 (0%) 0/114 (0%)
    Retinal tear0/243 (0%) 1/129 (0.8%) 0/127 (0%) 0/129 (0%) 0/114 (0%) 0/111 (0%) 0/114 (0%)
    Gastrointestinal disorders
    Abdominal wall haematoma0/243 (0%) 0/129 (0%) 0/127 (0%) 1/129 (0.8%) 0/114 (0%) 0/111 (0%) 0/114 (0%)
    Ileus0/243 (0%) 0/129 (0%) 0/127 (0%) 1/129 (0.8%) 0/114 (0%) 0/111 (0%) 0/114 (0%)
    Hepatobiliary disorders
    Cholecystitis acute0/243 (0%) 0/129 (0%) 0/127 (0%) 0/129 (0%) 0/114 (0%) 0/111 (0%) 1/114 (0.9%)
    Cholelithiasis0/243 (0%) 0/129 (0%) 0/127 (0%) 1/129 (0.8%) 0/114 (0%) 0/111 (0%) 1/114 (0.9%)
    Infections and infestations
    Diverticulitis0/243 (0%) 0/129 (0%) 0/127 (0%) 1/129 (0.8%) 0/114 (0%) 0/111 (0%) 0/114 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast neoplasm0/243 (0%) 0/129 (0%) 0/127 (0%) 0/129 (0%) 0/114 (0%) 0/111 (0%) 1/114 (0.9%)
    Product Issues
    Device dislocation0/243 (0%) 0/129 (0%) 1/127 (0.8%) 0/129 (0%) 1/114 (0.9%) 0/111 (0%) 0/114 (0%)
    Renal and urinary disorders
    Acute kidney injury0/243 (0%) 0/129 (0%) 0/127 (0%) 0/129 (0%) 0/114 (0%) 0/111 (0%) 1/114 (0.9%)
    Surgical and medical procedures
    Colectomy0/243 (0%) 0/129 (0%) 0/127 (0%) 1/129 (0.8%) 0/114 (0%) 0/111 (0%) 0/114 (0%)
    Intra-ocular injection0/243 (0%) 1/129 (0.8%) 2/127 (1.6%) 1/129 (0.8%) 1/114 (0.9%) 1/111 (0.9%) 0/114 (0%)
    Intraocular lens repositioning0/243 (0%) 0/129 (0%) 1/127 (0.8%) 0/129 (0%) 0/114 (0%) 0/111 (0%) 0/114 (0%)
    Lens extraction0/243 (0%) 1/129 (0.8%) 0/127 (0%) 0/129 (0%) 1/114 (0.9%) 0/111 (0%) 0/114 (0%)
    Vitrectomy0/243 (0%) 0/129 (0%) 1/127 (0.8%) 0/129 (0%) 0/114 (0%) 0/111 (0%) 0/114 (0%)
    Other (Not Including Serious) Adverse Events
    PreoperativeTFNT00 - 1st EyeTFNT00 - 2nd EyeTFNT00 - SystemicSN60AT - 1st EyeSN60AT - 2nd EyeSN60AT - Systemic
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total1/243 (0.4%) 24/129 (18.6%) 24/127 (18.9%) 0/129 (0%) 10/114 (8.8%) 7/111 (6.3%) 0/114 (0%)
    Eye disorders
    Posterior capsule opacification0/243 (0%) 17/129 (13.2%) 19/127 (15%) 0/129 (0%) 4/114 (3.5%) 5/111 (4.5%) 0/114 (0%)
    Investigations
    Intraocular pressure increased1/243 (0.4%) 7/129 (5.4%) 5/127 (3.9%) 0/129 (0%) 6/114 (5.3%) 2/111 (1.8%) 0/114 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

    Results Point of Contact

    Name/TitleExpert Clinical Project Lead, CDMA Surgical
    OrganizationAlcon Research
    Phone1-888-451-3937
    Emailalcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03280108
    Other Study ID Numbers:
    • ILH297-C001
    First Posted:
    Sep 12, 2017
    Last Update Posted:
    Oct 10, 2019
    Last Verified:
    Oct 1, 2019